Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. |
| Product | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. |
| Quantity | 160 sites potentially have the affected versions |
| Distribution | USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution. |
| Initiated | 2017-05-24 |
| Classified | 2017-06-16 |
| Terminated | 2019-10-15 |
| Recall number | Z-2601-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-2601-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77271/
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